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The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals and Its Effect on Iron Status of Rural Indian Children (6-10 Years) (MUGUST_2)

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ClinicalTrials.gov Identifier: NCT01191463
Recruitment Status : Completed
First Posted : August 30, 2010
Last Update Posted : September 29, 2011
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Iron deficiency is estimated to affect about one fifth of the world's population, and women and children are among the most severely affected. Evidence is mounting that iron deficiency anemia adversely affects brain development with measurable effects on children's behavior, motor development and cognition. In Hisar district of Haryana state, north- India, 58% of school age children (6-10 years) are anemic, 49 % are iron deficient whereas 40 % have been found to be anemic due to iron deficiency. Iron bioavailability calculated using algorithms in regional diets ranged from 3.2 to 4.6 percent. Mungbean (Vigna radiata L.) is the third most important legume crop of India. It is a high potential legume crop with 4-8 mg of iron and known as a nutritious and healthy legume. Ascorbic acid is a potent enhancer of iron absorption in humans which can counteract the inhibitory effect of phytic acid and polyphenols. Guava is a popular and easily available fruit for this community having 200- 300 mg/100g of ascorbic acid. We will conduct a randomised controlled trial in school age children (6-10 years) in Haryana state of India, to determine the efficacy of local vitamin-C rich fruit guava with mungbean based meal on iron status of rural Indian children.

Objective: To assess the effect of mungbean based test meal on iron status (as body iron stores, defined and calculated by the ratio of serum ferritin and serum transferrin receptor) of school age children (6-10 years) with and without the consumption of guava, a vitamin C rich fruit, in a school feeding program for seven months.

Study population: Three hundred school children aged between 6-10 years will be recruited from two government school of Mangali village situated in Hisar district of Haryana state.

Study design: This intervention study will be carried out in a randomized controlled design. Main study parameters/endpoints: Primary outcome will be the measurement of body iron stores (mg/kg of body weight) based on the ratio of serum transferrin receptor to serum ferritin.


Condition or disease Intervention/treatment
Iron Deficiency Anemia Other: Mung Bean Meal Other: Guava

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Efficacy of a Local Vitamin-C Rich Fruit (Guava) in Improving Iron Absorption From Mungbean Based Meals in Indian Children (6-10 Years)
Study Start Date : September 2010
Primary Completion Date : April 2011
Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron Vitamin C
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Mung Bean Meals and Guava fruit
Subject in this group will receive, a lunch meal based on 50g of Mung beans together with a local, Vitamin C rich fruit (Guava)
Other: Mung Bean Meal
50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.
Other: Guava
A fresh Guava fruit will be provided raw (approx 100g fresh weight)
Active Comparator: Mung Bean
Subjects in this group will receive a lunch meal based on 50g mung beans but without any vitamin C source.
Other: Mung Bean Meal
50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.
No Intervention: School feeding program
Subjects in this arm, will receive the regular school feeding program as provided by the school authorities


Outcome Measures

Primary Outcome Measures :
  1. Body Iron Stores [ Time Frame: Baseline (Start month=0), End of study (Month=7) ]
    Defined as the ration between serum ferritin and soluble serum transferrin recpetor Body iron stores are a sensitive measure of body iron balance and indicative of body iron changes.


Secondary Outcome Measures :
  1. Prevalence of iron deficiency, Prevalence of Iron deficiency anemia [ Time Frame: Begin (Month=0), End (Month=7) ]
    Anemia will be defined as a hemoglobin concentration <11.5g/L and iron deficiency will be defined as an SF concentration <12µg/l.


Eligibility Criteria

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Ages Eligible for Study:   6 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • School children (6-10) years of age
  • Enrolled in selected primary schools
  • Informed consent obtained from at least one parent or guardian
  • Children should be apparently healthy; i.e. have no pre-existing medical conditions or be receiving chronic medication.
  • Should not be allergic / hypersensitive to any of the ingredients of the test meal
  • Should not consume mineral/vitamin supplements. If the child consume supplements he/she will be asked to stop taking the supplements two weeks before the study and during the study

Exclusion Criteria:

  • Subjects with severe anemia (Hb=70 g/L)will be referred for treatement at the local health facility.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01191463


Locations
India
CCS Haryana Agricultural University
Hisar, Haryana State, India
Sponsors and Collaborators
Wageningen University
CCS Haryana Agricultural University Hisar, India
Investigators
Principal Investigator: Varsha Rani, PhD Wageningen University, Haryana University
More Information

Additional Information:
Publications:
Rani, V., Brouwer, Inge., Khetarpaul, N., Zimmerman, M.B. (2009) Iron status and associated factors in rural school going children (5-8 years) of Haryana state, India., Abstract Book Wageningen Nutritional Sciences Forum March 4-6, 2009 European Journal of Clinical Nutrition, 63 (3S) Pp:20

Responsible Party: Wageningen University
ClinicalTrials.gov Identifier: NCT01191463     History of Changes
Other Study ID Numbers: MUGUST_2
First Posted: August 30, 2010    Key Record Dates
Last Update Posted: September 29, 2011
Last Verified: September 2010

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents